Abstract
Purpose :
Dry eye disease (DED) treatment limitations include discomfort, poor compliance, delayed or limited effects, and high costs. We evaluated the occlusive capacity of a novel canalicular implant composed of a thermosensitive, anatomically adaptable gel, as a reliable treatment for DED.
Methods :
A first-in-human study (NCT05748951) enrolled participants with moderate to severe signs and symptoms of DED at a cornea specialty clinic. Phase-changing (liquid-to-solid) hydrogel was deployed by a novel autoinjector to the lower canaliculus of each eye. Participants received standard-of-care ocular assessments at four visits over 3 months. Assessments included Schirmer Tear Test I (STT), Ocular Surface Disease Index (OSDI), Corneal Fluorescein Staining (CFS), and adverse event monitoring. At the final follow-up, the gel was removed by saline irrigation.
Results :
Forty-four eyes of 22 patients (2M:20F) were evaluated (55±10.7 years old). The primary endpoint was STT in the protocol-specified eye, which increased from a mean of 4.8 ± 3.0 at baseline to 6.7 ± 3.9 at week 2 and 7.3 ± 6.3 at 12 weeks; 47% (p=0.036) and 53% (p=0.076) increases, respectively[AG1]. The mean CFS score (average of both eyes) on the NEI grading scale decreased from 8.3 ± 3.3 at baseline to 4.3 ± 3.7 at week 2 and 2.9 ± 3.8 at week 12; a 48% (p<0.001) and 66% (p<0.001) reduction, respectively. The mean OSDI score decreased from 59.1±16.8 at baseline to 18.3±12.2 at week 2 and 8.1±7.6 at week 12; a 69% (p<0.001) and 86% (p<0.001) decrease, respectively. Post-hoc analysis of epithelial fluorometry imaging using an automated system confirmed confidence in the above findings with a 59% (p<0.001) CFS reduction after 3 months. Safety endpoints included adverse event monitoring and confirmation of gel removal. Intervention-related adverse events were not observed.
Conclusions :
These results support the safety of a responsive gel for canalicular occlusion and show a positive impact on several DED clinical indicators. Increased tear availability resulted in symptom reduction and healing of damaged corneal epithelium in patients with DED. If the clinical effect is confirmed by a powered, controlled clinical trial, this could represent an attractive treatment option for patients experiencing DED and dry eye-related discomfort.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.